Chromium Picolinate Tablets
DEFINITION
Chromium Picolinate Tablets contain NLT 95.0% and NMT 125.0% of the labeled amount of chromium (Cr).
IDENTIFICATION
• A.
The Sample solution prepared as directed in the test for Strength gives a positive test for chromium, determined at 357.9 nm using the Instrumental conditions in the test for Content of Chromium.
STRENGTH
• Content of Chromium
Standard stock solution A:
1000 µg/mL of chromium from potassium dichromate, previously dried at 120 for 4 h, in water. Store in a polyethylene bottle.
Standard stock solution B:
Transfer 1.0 mL of Standard stock solution A to a 100-mL volumetric flask, add 5.0 mL of 6 N hydrochloric acid, and dilute with water to volume to obtain a solution having a concentration of 10 µg/mL of chromium.
Standard solutions:
Dilute Standard stock solution B with 0.125 N hydrochloric acid to obtain concentrations of 1.0, 2.0, 3.0, and 4.0 µg/mL of chromium.
Sample solution:
Weigh and finely powder NLT 20 Tablets. Transfer a portion of the powder, equivalent to 5 Tablets, to a porcelain crucible, heat the crucible in a muffle furnace maintained at about 550 for 612 h, and cool. Add 60 mL of hydrochloric acid, and boil gently on a hot plate or steam bath for 30 min, intermittently rinsing the inner surface of the crucible with 6 N hydrochloric acid. Cool, and transfer the contents of the crucible to a 100-mL volumetric flask. Rinse the crucible with small portions of 6 N hydrochloric acid, and add the rinsings to the flask. Dilute with water to volume, mix, and filter, discarding the first 5 mL of the filtrate. Dilute this solution with 0.125 N hydrochloric acid to obtain a solution having a concentration of 2.5 µg/mL of chromium.
Instrumental conditions
Mode:
Atomic absorption spectrophotometry
Lamp:
Chromium hollow-cathode
Flame:
Airacetylene
Analytical wavelength:
357.9 nm (chromium emission line)
Blank:
0.125 N hydrochloric acid
Analysis
Samples:
Standard solutions and Sample solution
Determine the absorbances of the Samples, using the Blank. From a linear regression equation, calculated using the absorbances of the Standard solutions versus the concentration, in µg/mL, of chromium, determine the concentration, C, in µg/mL, of chromium in the Sample solution.
Calculate the percentage of the labeled amount of chromium (Cr) in the portion of Tablets taken:
Result = (C/CU) × 100
Acceptance criteria:
95.0%125.0%
PERFORMANCE TESTS
• Disintegration and Dissolution of Dietary Supplements 2040:
Meet the requirements for Disintegration
• Weight Variation of Dietary Supplements 2091:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers, and store at controlled room temperature.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 1251
Pharmacopeial Forum: Volume No. 30(5) Page 1664
|